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A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
trastuzumab
trastuzumab emtansine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient, >/= 18 years of age
  • HER2-positive breast cancer
  • Histologically confirmed invasive breast carcinoma
  • Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
  • Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
  • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
  • Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
  • An interval of no more than 12 weeks between the date of surgery and the date of randomization
  • Known hormone-receptor status
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic, renal and liver function
  • Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.
  • For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug
  • Documentation of hepatitis B virus and hepatitis C virus serology is required

Exclusion Criteria:

  • Stage IV (metastatic) breast cancer
  • History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
  • Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
  • Progressive disease during preoperative systemic therapy
  • Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
  • History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
  • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
  • Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
  • History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2
  • Cardiopulmonary dysfunction as defined by protocol
  • Prior treatment with trastuzumab emtansine
  • Current severe, uncontrolled systemic disease
  • Pregnant or lactating women
  • Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
  • Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
  • History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product

Sites / Locations

  • Providence Alaska Medical Center
  • Todd Cancer Institute at Long Beach Memorial Medical Center
  • Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
  • Stanford University Medical Center
  • Kaiser Permanente - San Diego
  • Breastlink Medical Group Inc
  • Kaiser Permanente - Vallejo
  • Kaiser Permanente - Franklin
  • Colorado Cancer Research Program/Admin
  • Rocky Mountain Cancer Centers - Colorado Springs (Circle)
  • Hartford Hospital
  • Yale Cancer Center
  • Washington Cancer Institute; Washington Hospital Center
  • University of Florida; Davis Cancer Pavilion and Shands Medical Plaza
  • Mount Sinai Medical Center
  • UF Health Orlando
  • Moffitt Cancer Center
  • Rush University Medical Center
  • Edward Cancer Center Naperville
  • Edward Cancer Center Plainfield
  • University of Iowa
  • University of Kentucky Medical Center
  • Norton Healthcare Inc.
  • Cancer Care of Maine
  • New England Cancer Specialists
  • Mercy Medical Center; Medical Oncology & Hematology
  • Greater Baltimore Medical Center
  • Med Star Franklin Square Medical Center/Weinburg Cancer Institute
  • Karmanos Cancer Institute
  • Henry Ford Health System
  • Spectrum Health Hospitals
  • Breslin Cancer Center
  • William Beaumont Hospital
  • US oncology research at Minnesota Oncology
  • Rutgers Cancer Institute of New Jersey
  • Sparta Cancer Center
  • Columbia University Medical Center
  • Troy Cancer Treatment Program
  • Carolinas Medical Center
  • Batte Cancer Center - Carolinas Medical Center
  • Sanford Roger Maris Cancer Center
  • Aultman Hospital; Aultman Hospital Cancer Center
  • Fairview Hospital; Cleveland Clinic Cancer Center
  • The Cleveland Clinic Foundation
  • Ohio State University, Arthur James Cancer Hospital
  • Lake Health/University Hospitals - Mentor Campus
  • Columbia River Oncology Program
  • Kimmel Cancer Center Thomas Jefferson University
  • Allegheny Cancer Center
  • Uni of Pittsburgh; Magee-Women'S Hospital
  • York Hospital
  • Medical University of South Carolina; Hollings Cancer Center
  • Avera Cancer Institute
  • Thompson Cancer Survival Center
  • Baylor College of Medicine
  • Houston Methodist Hospital Outpatient Center
  • Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
  • Joe Arrington Cancer Research & Treatment Center
  • Hematology Oncology Associates of Fredericksburg, Inc.
  • Lynchburg Hem Onc Clinic Inc
  • Virginia Commonwealth University - Massey Cancer Center
  • Swedish Cancer Institute - Issaquah
  • PeaceHealth St. John Medical Center - Lower Columbia Cancer Center
  • Cancer Care Northwest
  • Marshfield Clinic
  • Fundación CENIT para la Investigación en Neurociencias
  • Centro Oncologico Riojano Integral (CORI)
  • Instituto de Oncología de Rosario
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
  • Cliniques Universitaires St-Luc
  • AZ Sint Lucas (Sint Lucas)
  • CHU Sart-Tilman
  • Sint Augustinus Wilrijk
  • Iop Instituto de Oncologia Do Parana
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Clinicas Oncologicas Integradas - COI
  • UPCO - Unidade de Pesquisas Clínicas em Oncologia
  • Hospital Moinhos de Vento
  • Hospital Nossa Senhora da Conceicao
  • Hospital de Cancer de Barretos
  • Instituto de Ensino e Pesquisa Sao Lucas - IEP
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Hospital Perola Byington
  • Hospital Sao Jose
  • Tom Baker Cancer Centre; Dept of Medicine
  • Cross Cancer Institute ; Dept of Medical Oncology
  • BC Cancer ? Surrey
  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
  • London Regional Cancer Centre
  • The Ottawa Hospital; Division of Infectious Diseases
  • Princess Margaret Cancer Center
  • CSSS champlain - Charles-Le Moyne
  • Centre Hospitalier de l?Université de Montréal (CHUM)
  • Jewish General Hospital
  • McGill University Health Centre - Glen Site
  • Hopital du Saint Sacrement
  • the First Hospital of Jilin University
  • Sun Yet-sen University Cancer Center
  • Guangdong General Hospital
  • Harbin Medical University Cancer Hospital
  • Shandong Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
  • Clinica del Country
  • Hospital Pablo Tobon Uribe
  • Oncomedica S.A.
  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Vseobecna fakultni nemocnice v Praze
  • Institut Sainte Catherine;Recherche Clinique
  • HOPITAL JEAN MINJOZ; Oncologie
  • Institut Bergonie; Oncologie
  • Centre Hospitalier Fleyriat; Oncologie/Hematologie
  • Centre Francois Baclesse; Comite Sein
  • Centre Jean Perrin; Oncologie
  • Centre de Cancerologie de la Sarthe, Clinique Victor Hugo SoReCOH
  • Institut Paoli Calmettes; Oncologie Medicale
  • Centre Val Aurelle Paul Lamarque; Recherche Clinique
  • Institut Curie; Oncologie Medicale
  • Hopital Saint Louis; Oncologie Medicale
  • HOPITAL TENON; Cancerologie Medicale
  • Centre Henri Becquerel; Oncologie Medicale
  • Centre Rene Huguenin; CONSULT SPECIALISEES
  • Centre Paul Strauss; Oncologie Medicale
  • Institut Gustave Roussy; Departement Oncologie Medicale
  • Hämatologie Onkologie im Zentrum MVZ GmbH
  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
  • Onkologische Schwerpunktpraxis Kurfürstendamm
  • HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
  • Studienzentrum Berlin City
  • Onkologische Schwerpunktpraxis Bielefeld
  • Klinikum Sindelfingen-Böblingen; Frauenklinik
  • St. Johannes-Hospital
  • Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
  • Universitätsklinikum Erlangen; Frauenklinik
  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Freiburg; Frauenklinik
  • Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
  • Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
  • Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
  • St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik
  • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
  • Diakovere Henriettenstift, Frauenklinik
  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  • Elisabeth-Krankenhaus Brustzentrum
  • Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
  • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
  • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
  • Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum
  • Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
  • Klinikum der Universität München; Frauenklinik - Onkologie II
  • Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer
  • MVZ Nordhausen gGmbH, Praxis Dr. Grafe
  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
  • St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
  • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
  • Klinikum am Steinenberg Frauenklinik
  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
  • Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
  • Robert-Bosch-Krankenhaus; Brustzentrum
  • Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung
  • Universitätsklinik Tübingen; Frauenklinik
  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
  • Marien-Hospital Witten; Frauenklinik Brustzentrum
  • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
  • Univ General Hosp Heraklion; Medical Oncology
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Grupo Angeles
  • Centro Oncológico Sixtino / Centro Oncológico SA
  • Queen Mary Hospital; Surgery
  • Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
  • Tuen Mun Hospital; Clinical Oncology
  • Cork Uni Hospital; Oncology Dept
  • Mater Misericordiae Uni Hospital; Oncology
  • Beaumont Hospital; Cancer Clinical Trials Unit
  • St Vincent'S Uni Hospital; Medical Oncology
  • Galway Uni Hospital; Oncology Dept
  • University Hospital Limerick - Oncology
  • Soroka Medical Center
  • Shaare Zedek Medical Center; Oncology Dept
  • Hadassah University Hospital - Ein Kerem
  • Rabin MC; Davidof Center - Oncology Institute
  • Sheba Medical Center; Tel Hashomer
  • Kaplan Medical Center; Oncology Inst.
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Università degli Studi Federico II; Clinica di Oncologia Medica
  • Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
  • Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
  • Az. Osp. Sant'Andrea; Oncologia Medica
  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Asst Papa Giovanni XXIII; Oncologia Medica
  • ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
  • Irccs Ospedale San Raffaele;Oncologia Medica
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
  • Istituto Europeo Di Oncologia
  • ASST DI MONZA; Oncologia Medica
  • Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
  • Ospedale Antonio Perrino; Oncologia Medica
  • Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
  • Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
  • Hospital Angeles Metropolitano; Room 220
  • Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir
  • Oaxaca Site Management Organization
  • Médicos Especialistas en Cáncer SC
  • Instituto Nacional de Cancerologia; Oncology
  • The Panama Clinic
  • Centro Oncologico America
  • Centro Medico Monte Carmelo
  • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
  • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
  • Hospital Nacional Guillermo Almenara Irigoyen; Oncology
  • Clinica San Borja
  • Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology
  • Oncology Institute of Vojvodina
  • Cape Town Oncology Trials
  • Hopelands Cancer Centre
  • Medical Oncology Centre of Rosebank; Oncology
  • Wits Donald Gordon Clinical Trial Centre; Medical Oncology
  • Cancercare
  • Private Oncology Centre
  • Hospital de Donostia; Servicio de Oncologia Medica
  • Hospital Severo Ochoa; Servicio de Oncologia
  • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
  • Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Hospital Universitario La Paz; Servicio de Oncologia
  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Hospital de Navarra; Servicio de Oncologia
  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • Hospital Universitario Dr. Peset; Servicio de Oncologia
  • Gävle Sjukhus; Onkologiska Kliniken
  • Skånes University Hospital, Skånes Department of Onclology
  • Karolinska Hospital; Oncology - Radiumhemmet
  • Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN
  • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
  • Taichung Veterans General Hospital; Dept of Surgery
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
  • VETERANS GENERAL HOSPITAL; Department of General Surgery
  • National Taiwan Uni Hospital; General Surgery
  • Chang Gung Medical Foundation - Linkou; Dept of Surgery
  • Uludag Uni Hospital; Oncology
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  • Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
  • Ege Uni Medical Faculty Hospital; Oncology Dept
  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
  • University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
  • Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
  • Bristol Haematology and Oncology centre
  • Royal Cornwall Hospital; Dept of Clinical Oncology
  • Castle Hill Hospital; The Queens Centre for Oncology and Haematology
  • North Devon District Hospital
  • Ninewells Hospital; Cancer Medicine
  • Huddersfield Royal Infirmary
  • Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
  • St Thomas Hospital; Medicine Div.
  • Charing Cross Hospital; Medical Oncology.
  • Christie Hospital Nhs Trust; Medical Oncology
  • Nottingham City Hospital; Oncology
  • Weston Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Trastuzumab

Trastuzumab emtansine

Arm Description

Outcomes

Primary Outcome Measures

Invasive Disease-free Survival (IDFS)
IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.

Secondary Outcome Measures

Invasive Disease-free Survival Including Second Primary Non-breast Cancer
IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). 3-year IDFS including second primary non-breast cancer event-free rates per treatment arm in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Disease-free Survival
Disease-free survival was defined as the time between randomization and the date of the first occurrence of an invasive disease-free survival event including second primary non-breast cancer event or contralateral or ipsilateral DCIS. 3-year DFS event-free rates per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Overall Survival (OS)
Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. 5 years OS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 5 years after treatment.
Distant Recurrence-Free Interval (DRFI)
DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3 years DRFI event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Percentage of Participants With Cardiac Dysfunction
Cardiac events were reported based on the NCI-CTCAE, v4.0.
Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in quality of life (QOL) and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in quality of life (QOL) and negative change from baseline indicated a deterioration in QOL.
Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1)
Blood and serum samples for measurement of trastuzumab emtansine, total trastuzumab, and DM1 will be obtained from patients randomized to the trastuzumab emtansine arm.
Serum Concentrations (AUC) of Trastuzumab
Serum blood samples were collected for trastuzumab measurement prior to dosing and 15-30 minutes post infusion for Cycle 1 and Cycle 4. Additional serum samples were collected at study treatment termination.
Plasma Concentrations of DM1
Trastuzumab Emtansine Exposure
Anti-trastuzumab Emtansine Antibody (ATA)
Anti-trastuzumab Antibody (ATA)

Full Information

First Posted
January 17, 2013
Last Updated
August 18, 2023
Sponsor
Hoffmann-La Roche
Collaborators
NSABP Foundation Inc, German Breast Group
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1. Study Identification

Unique Protocol Identification Number
NCT01772472
Brief Title
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
Official Title
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 3, 2013 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
April 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
NSABP Foundation Inc, German Breast Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1487 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trastuzumab
Arm Type
Active Comparator
Arm Title
Trastuzumab emtansine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Description
6 mg/kg intravenously every 3 weeks, 14 cycles
Intervention Type
Drug
Intervention Name(s)
trastuzumab emtansine
Intervention Description
3.6 mg/kg intravenously every 3 weeks, 14 cycles
Primary Outcome Measure Information:
Title
Invasive Disease-free Survival (IDFS)
Description
IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time Frame
From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months)
Secondary Outcome Measure Information:
Title
Invasive Disease-free Survival Including Second Primary Non-breast Cancer
Description
IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). 3-year IDFS including second primary non-breast cancer event-free rates per treatment arm in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time Frame
From baseline up to 12 years
Title
Disease-free Survival
Description
Disease-free survival was defined as the time between randomization and the date of the first occurrence of an invasive disease-free survival event including second primary non-breast cancer event or contralateral or ipsilateral DCIS. 3-year DFS event-free rates per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time Frame
From baseline up to 12 years
Title
Overall Survival (OS)
Description
Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. 5 years OS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 5 years after treatment.
Time Frame
Baseline up to 12 years
Title
Distant Recurrence-Free Interval (DRFI)
Description
DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3 years DRFI event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.
Time Frame
Baseline up to 12 years
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Time Frame
From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months)
Title
Percentage of Participants With Cardiac Dysfunction
Description
Cardiac events were reported based on the NCI-CTCAE, v4.0.
Time Frame
From baseline up to 12 years
Title
Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
Description
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Time Frame
Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12
Title
Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
Description
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in quality of life (QOL) and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in quality of life (QOL) and negative change from baseline indicated a deterioration in QOL.
Time Frame
Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12
Title
Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1)
Description
Blood and serum samples for measurement of trastuzumab emtansine, total trastuzumab, and DM1 will be obtained from patients randomized to the trastuzumab emtansine arm.
Time Frame
Cycle (C) 1, Day (D) 1 and C4D1 of pre-infusion, C1D1 and C4D1 post-infusion, C2D1 and C5D1 pre-infusion and study treatment termination
Title
Serum Concentrations (AUC) of Trastuzumab
Description
Serum blood samples were collected for trastuzumab measurement prior to dosing and 15-30 minutes post infusion for Cycle 1 and Cycle 4. Additional serum samples were collected at study treatment termination.
Time Frame
C1D1 and C4D1 of post-infusion and study treatment termination
Title
Plasma Concentrations of DM1
Time Frame
Day 1 on Cycles 1 and 4. Each cycle is 21 days.
Title
Trastuzumab Emtansine Exposure
Time Frame
Day 1 on Cycles 1, 2, 4 and 5, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Title
Anti-trastuzumab Emtansine Antibody (ATA)
Time Frame
Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.
Title
Anti-trastuzumab Antibody (ATA)
Time Frame
Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient, >/= 18 years of age HER2-positive breast cancer Histologically confirmed invasive breast carcinoma Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible) Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy An interval of no more than 12 weeks between the date of surgery and the date of randomization Known hormone-receptor status Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate hematologic, renal and liver function Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy. For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug Documentation of hepatitis B virus and hepatitis C virus serology is required Exclusion Criteria: Stage IV (metastatic) breast cancer History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery Progressive disease during preoperative systemic therapy Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2 Cardiopulmonary dysfunction as defined by protocol Prior treatment with trastuzumab emtansine Current severe, uncontrolled systemic disease Pregnant or lactating women Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis Concurrent serious uncontrolled infections requiring treatment or known infection with HIV History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Todd Cancer Institute at Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Kaiser Permanente - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Breastlink Medical Group Inc
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Kaiser Permanente - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente - Franklin
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Colorado Cancer Research Program/Admin
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Colorado Springs (Circle)
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Washington Cancer Institute; Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida; Davis Cancer Pavilion and Shands Medical Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
UF Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Edward Cancer Center Naperville
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Edward Cancer Center Plainfield
City
Plainfield
State/Province
Illinois
ZIP/Postal Code
60585
Country
United States
Facility Name
University of Iowa
City
Lowa City
State/Province
Iowa
ZIP/Postal Code
52242-1086
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Healthcare Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Cancer Care of Maine
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Mercy Medical Center; Medical Oncology & Hematology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Med Star Franklin Square Medical Center/Weinburg Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Breslin Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
US oncology research at Minnesota Oncology
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Sparta Cancer Center
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871-1791
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Troy Cancer Treatment Program
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204-2839
Country
United States
Facility Name
Batte Cancer Center - Carolinas Medical Center
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Aultman Hospital; Aultman Hospital Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Fairview Hospital; Cleveland Clinic Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University, Arthur James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lake Health/University Hospitals - Mentor Campus
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kimmel Cancer Center Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Uni of Pittsburgh; Magee-Women'S Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Medical University of South Carolina; Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916-2305
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital Outpatient Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Joe Arrington Cancer Research & Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Hematology Oncology Associates of Fredericksburg, Inc.
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Lynchburg Hem Onc Clinic Inc
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Commonwealth University - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Cancer Institute - Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
PeaceHealth St. John Medical Center - Lower Columbia Cancer Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Instituto de Oncología de Rosario
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Sint Lucas (Sint Lucas)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Iop Instituto de Oncologia Do Parana
City
Curitiba
State/Province
PR
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Clinicas Oncologicas Integradas - COI
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
22290-160
Country
Brazil
Facility Name
UPCO - Unidade de Pesquisas Clínicas em Oncologia
City
Pelotas
State/Province
RS
ZIP/Postal Code
96020-080
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa Sao Lucas - IEP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Perola Byington
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Hospital Sao Jose
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Tom Baker Cancer Centre; Dept of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute ; Dept of Medical Oncology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer ? Surrey
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital; Division of Infectious Diseases
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
CSSS champlain - Charles-Le Moyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Centre Hospitalier de l?Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C2
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill University Health Centre - Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Clinica del Country
City
Bogota
ZIP/Postal Code
11001
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Institut Sainte Catherine;Recherche Clinique
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
HOPITAL JEAN MINJOZ; Oncologie
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier Fleyriat; Oncologie/Hematologie
City
Bourg En Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Centre Francois Baclesse; Comite Sein
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin; Oncologie
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre de Cancerologie de la Sarthe, Clinique Victor Hugo SoReCOH
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Institut Paoli Calmettes; Oncologie Medicale
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Val Aurelle Paul Lamarque; Recherche Clinique
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Hopital Saint Louis; Oncologie Medicale
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
HOPITAL TENON; Cancerologie Medicale
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Centre Henri Becquerel; Oncologie Medicale
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin; CONSULT SPECIALISEES
City
St Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Centre Paul Strauss; Oncologie Medicale
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Gustave Roussy; Departement Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Hämatologie Onkologie im Zentrum MVZ GmbH
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Studienzentrum Berlin City
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Bielefeld
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Klinikum Sindelfingen-Böblingen; Frauenklinik
City
Böblingen
ZIP/Postal Code
71032
Country
Germany
Facility Name
St. Johannes-Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
City
Düsseldorf
ZIP/Postal Code
40235
Country
Germany
Facility Name
Universitätsklinikum Erlangen; Frauenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
City
Frankfurt am Main
ZIP/Postal Code
60389
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitätsklinikum Freiburg; Frauenklinik
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik
City
Hamm
ZIP/Postal Code
59073
Country
Germany
Facility Name
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
City
Hannover
ZIP/Postal Code
30177
Country
Germany
Facility Name
Diakovere Henriettenstift, Frauenklinik
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Elisabeth-Krankenhaus Brustzentrum
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum
City
Köln
ZIP/Postal Code
51067
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
City
Lebach
ZIP/Postal Code
66822
Country
Germany
Facility Name
Klinikum der Universität München; Frauenklinik - Onkologie II
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer
City
München
ZIP/Postal Code
80638
Country
Germany
Facility Name
MVZ Nordhausen gGmbH, Praxis Dr. Grafe
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
Facility Name
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
Klinikum am Steinenberg Frauenklinik
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
City
Stralsund
ZIP/Postal Code
18439
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus; Brustzentrum
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung
City
Traunstein
ZIP/Postal Code
83278
Country
Germany
Facility Name
Universitätsklinik Tübingen; Frauenklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Marien-Hospital Witten; Frauenklinik Brustzentrum
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Facility Name
Grupo Angeles
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Centro Oncológico Sixtino / Centro Oncológico SA
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Queen Mary Hospital; Surgery
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Facility Name
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Cork Uni Hospital; Oncology Dept
City
Cork
Country
Ireland
Facility Name
Mater Misericordiae Uni Hospital; Oncology
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Beaumont Hospital; Cancer Clinical Trials Unit
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
St Vincent'S Uni Hospital; Medical Oncology
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Galway Uni Hospital; Oncology Dept
City
Galway
Country
Ireland
Facility Name
University Hospital Limerick - Oncology
City
Limerick
Country
Ireland
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Shaare Zedek Medical Center; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin MC; Davidof Center - Oncology Institute
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center; Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Kaplan Medical Center; Oncology Inst.
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università degli Studi Federico II; Clinica di Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Az. Osp. Sant'Andrea; Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Irccs Ospedale San Raffaele;Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
ASST DI MONZA; Oncologia Medica
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale Antonio Perrino; Oncologia Medica
City
Brindisi
State/Province
Puglia
ZIP/Postal Code
72100
Country
Italy
Facility Name
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
City
Pontedera
State/Province
Toscana
ZIP/Postal Code
56025
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Hospital Angeles Metropolitano; Room 220
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Médicos Especialistas en Cáncer SC
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Instituto Nacional de Cancerologia; Oncology
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
The Panama Clinic
City
Panama
ZIP/Postal Code
0832-02723
Country
Panama
Facility Name
Centro Oncologico America
City
Panama
ZIP/Postal Code
0834-02723
Country
Panama
Facility Name
Centro Medico Monte Carmelo
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
City
Bellavista
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen; Oncology
City
Lima
ZIP/Postal Code
13
Country
Peru
Facility Name
Clinica San Borja
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Oncology Institute of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Cape Town Oncology Trials
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Hopelands Cancer Centre
City
Hilton
ZIP/Postal Code
3245
Country
South Africa
Facility Name
Medical Oncology Centre of Rosebank; Oncology
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
City
Parktown, Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Cancercare
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Private Oncology Centre
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Hospital de Donostia; Servicio de Oncologia Medica
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
Facility Name
Hospital Severo Ochoa; Servicio de Oncologia
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital de Navarra; Servicio de Oncologia
City
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario Dr. Peset; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Gävle Sjukhus; Onkologiska Kliniken
City
Gävle
ZIP/Postal Code
80187
Country
Sweden
Facility Name
Skånes University Hospital, Skånes Department of Onclology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska Hospital; Oncology - Radiumhemmet
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
Taichung Veterans General Hospital; Dept of Surgery
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
City
Taipei City
ZIP/Postal Code
11259
Country
Taiwan
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; General Surgery
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Dept of Surgery
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Uludag Uni Hospital; Oncology
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
Facility Name
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
City
Istanbul
ZIP/Postal Code
34865
Country
Turkey
Facility Name
Ege Uni Medical Faculty Hospital; Oncology Dept
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Royal Cornwall Hospital; Dept of Clinical Oncology
City
Cornwall
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Facility Name
Castle Hill Hospital; The Queens Centre for Oncology and Haematology
City
Cottingham
ZIP/Postal Code
HU16 5JG
Country
United Kingdom
Facility Name
North Devon District Hospital
City
Devon
ZIP/Postal Code
EX31 4JB
Country
United Kingdom
Facility Name
Ninewells Hospital; Cancer Medicine
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St Thomas Hospital; Medicine Div.
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Charing Cross Hospital; Medical Oncology.
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
Facility Name
Nottingham City Hospital; Oncology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30516102
Citation
von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.
Results Reference
derived

Learn more about this trial

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

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